SEC Company Response from Edwards Lifesciences Corp (EW) (CIK 0001099800) (EW) — Dec 22, 2005
Edwards Lifesciences Corp (EW) (CIK 0001099800)
Date: Dec. 22, 2005 · CIK: 0001099800 · Accession: 0001104659-05-062334
AI Filing Summary & Sentiment
Referenced dates: December 8, 2005
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CORRESP 1 filename1.htm Edwards Lifesciences Corporation One Edwards Way Irvine, California 92614 Telephone: (949) 250-2500 December 22, 2005 Mr. Jay Webb Reviewing Accountant Mail Stop 6010 U.S. Securities and Exchange Commission 701 First Street, N.E. Washington, D.C. 20549 RE: Edwards Lifesciences Corporation Form 10-K for fiscal year ended December 31, 2004 Filed March 7, 2005 File No. 1-15525 Form 8-K filed October 25, 2005 Dear Mr. Webb: Set forth below are the comments from the Staff’s letter dated December 8, 2005 with respect to Edwards Lifesciences Corporation (the “Company”) Form 10-K as filed with the SEC on March 7, 2005, and Form 8-K as filed on October 25, 2005, and the Company’s responses to those comments. Form 10-K for the year-end December 31, 2004 Notes to Financial Statements, page 53 Note 2 Summary of Significant Accounting Policies, page 53 Investment in Unconsolidated Affiliates, page 57 STAFF COMMENT 1. We see that as of December 31, 2004, Edwards Lifesciences had a $7.5 million unrealized loss related to a $12.6 million investment in a publicly traded company. You indicate that trading value of the investment has been less than the original cost for greater than one year. We also see disclosures in your 2003 Form 10-K that indicate the investment had an unrealized loss of $7.3 million as of December 31, 2003. Please tell us why you believe this impairment is temporary. Tell us when you made the investment and the name of the company. Please describe your investment impairment analysis and conclusions for each quarterly period this investment has been trading at values below your historical cost. Provide us with market information regarding the high and low trading range and closing value of this stock for each quarterly period during 2003 to the present. Consider the guidance at Staff Accounting Bulletin Topic 5M and EITF 03-1 when preparing your response to our comment. We may have further comments after reviewing your response. COMPANY RESPONSE Summary The Staff’s comment refers to the Company’s investment in Sangamo Biosciences, Inc. [NASDAQ: SGMO] (“Sangamo”). The Company regularly conducts an investment impairment analysis. When doing so for the third quarter 2005, the Company concluded (prior to the receipt of the Staff’s December 8, 2005 letter) that the impairment of the investment in Sangamo was other-than-temporary and therefore reclassified $8.9 million of unrealized loss from equity to current earnings (see the Company’s Form 10-Q for the quarterly period ended September 30, 2005, page 7). For prior periods, the Company concluded that the impairment was temporary, as described below. Sangamo Investment Sangamo is a biotechnology firm that has developed a platform gene regulation technology and applied it to a variety of commercial opportunities including drug discovery, therapeutic development, gene correction, manufacture of protein pharmaceuticals, validation of gene targets and agricultural biotechnology. These applications by nature have long-term horizons for demonstrating progress and generating value, driven principally by (1) therapeutic programs successfully progressing through their development phases into the clinic; and (2) third party validation of the technology platform in the form of collaborative partnerships and alliances. In the first quarter of 2000, the Company entered into a long-term strategic alliance with Sangamo to continue to develop certain technology, as follows: • The Company invested $12.6 million in Sangamo in exchange for a 5-year debenture, convertible into Sangamo common stock upon completion of an initial public offering or a sale of its business. • Sangamo licensed certain technology to the Company in exchange for the Company’s obligation to make certain milestone payments. These payments are expensed by the Company as incurred. 2 On April 6, 2000, Sangamo successfully raised $48.8 million in an initial public offering of 3.5 million common shares at $15.00 per share, and the debenture converted into 842,454 shares of Sangamo common stock with a basis of $14.84 per share. Investment Impairment Accounting Guidance The Company performs a quarterly investment impairment analysis on its investments to determine whether any other-than-temporary impairments exist. Management considers the guidance of FAS 115, Accounting for Certain Investments in Debt & Equity Securities, paragraph 16, as well as the guidance in SEC Staff Accounting Bulletin 59 (SAB Topic 5M), “Accounting for Noncurrent Marketable Equity Securities.” This bulletin identified several factors which, individually or in combination, may indicate that a decline is other-than-temporary and that a write-down of the carrying value may be required, including: a. The length of the time and the extent to which the market value has been less than cost; b. The financial condition and near-term prospects of the issuer, including any specific events which may influence the operations of the issuer such as changes in technology that may impair the earnings potential of the investment or the discontinuance of a segment of the business that may affect the future earnings potential; or c. The intent and ability of the holder to retain its investment in the issuer for a period of time sufficient to allow for any anticipated recovery in market value. SAB Topic 5M further requires that “…management…consider all available evidence to evaluate the realizable value of its investment.” The Company also considered the guidance contained in EITF 03-01, FSP EITF 03-1, and FSP Nos. FAS 115-1 and FAS 124-1 for each of the relevant periods in which these standards were effective in evaluating whether investment impairments were other-than-temporary. Investment Impairment Analysis The Company has consistently viewed Sangamo as a long-cycle biotechnology company with multiple business initiatives underway. The platform nature of Sangamo’s technology provides multiple points for increasing enterprise value ranging from therapeutic applications to enabling technology alliances or partnerships. Value is driven by successful progress in the clinic with multiple therapeutic programs (including the Company’s cardiovascular initiative) and the growing number of enabling technology partnerships around gene tools, cell lines, protein production and plant agriculture. Broader biotechnology market sentiment may influence Sangamo’s short-term valuation, but, in the Company’s view, did not impact Sangamo’s underlying value. 3 The Company’s quarterly investment impairment analysis for its Sangamo investment generally included review and analysis of several factors, including: 1. The Company’s discussions with Sangamo’s management to review the status of key internally established development milestones as they relate to Sangamo’s technology. As a result of the Company’s strategic alliance with Sangamo, the Company regularly had access to information regarding technology development that was generally not available to the investor community. 2. The Company’s review of key ongoing clinical trial progress, including the number of patients enrolled, status of treatments, as well as new requests for additional clinical trials. The Company reviewed ongoing progress and development of the licensed technology with its research and development professionals. In addition, Sangamo scientists made regular presentations to the Company’s Scientific Advisory Board on the progress of Sangamo’s underlying technology. This information also was generally not available to the investor community. 3. The Company’s knowledge of Sangamo’s activities relating to new collaboration agreements, new investor funding and milestone achievements or technology breakthroughs. 4. The Company’s review of Sangamo’s financial position, primarily the cash resources and operating cash flow, to determine if cash levels were sufficient to continue to fund projected operations and ongoing technology development. Investment Impairment Considerations The Company considered numerous facts, including those described below, to conclude impairment of the Sangamo investment was temporary in nature as of the end of each of the quarters in 2003 and 2004, and the first two quarters of 2005: 1. Development Milestones. Sangamo’s key internally established development milestones were progressing and/or remained on track at each quarter-end throughout 2003, 2004 and the first two quarters of 2005. There were no changes in technology that could impair Sangamo’s earnings potential of the investment and the technological progress supported a positive outlook. The Company had knowledge and a deeper understanding of some of the development milestones prior to the investor community, including: a. In 2003: Sangamo’s active pre-clinical therapeutic programs (either directly or through partners) had increased from six to nine — all actively under development and generating pre-clinical data. The Company’s ischemic cardiovascular program, using Sangamo-licensed technology, 4 was making rapid progress and had broadened to include an indication for treating ischemic heart disease in addition to peripheral artery disease. In June, Sangamo announced pre-clinical animal efficacy for a program to develop a novel treatment for ischemic cardiovascular and peripheral vascular disease. The results were very encouraging and validated the program to develop this technology. In December, the Company announced that it expected to file an Investigational New Drug (“IND”) application for the licensed technology with the U.S. Food and Drug Administration (“FDA”) in the first quarter of 2004. b. In 2004 and the first half of 2005: Sangamo’s active pre-clinical therapeutic programs (either directly or through partners) had increased from nine to fourteen — all actively under development and generating pre-clinical data. In February, Sangamo and the Company announced the filing of an IND application for FDA clearance with the Phase I/II trials to begin in the first half of 2004. In March, FDA clearance was received to commence the first clinical trial of the drug that the Company had licensed. The National Institutes for Health agreed to provide funding to conduct the clinical trials. In June, Sangamo announced positive pre-clinical animal efficacy data for its diabetic neuropathy program and its intention to file an IND for this indication. Also, in the second quarter, the National Institutes for Health screened 77 patients for the clinical trials, of which 30 qualified, 17 signed to participate, and 9 were under evaluation. By the fourth quarter of 2004, five patients had been treated, with two more patients treated by June 2005. It was originally anticipated that full enrollment would be completed by the first quarter of 2006, a normal time horizon for clinical trials. During the fourth quarter, Sangamo’s technology platform received further validation from two leading university hospitals’ interest in the technology licensed to the Company. Yale University School of Medicine requested the Company to conduct a Phase I clinical trial on ischemic heart disease. Discussions are still ongoing. Also during the fourth quarter, Duke University School of Medicine offered to conduct a Phase I clinical trial for critical limb ischemia after having demonstrated success in a pre-clinical animal model. The Company submitted and filed an IND application in the first quarter of 2005, and the trial commenced in the second quarter of 2005 and has already enrolled 10 patients. 5 The Company continued to believe that the number and scope of Sangamo’s programs, the range of its third party collaborations and the continued success in the Company’s Sangamo-related programs would significantly drive the value of Sangamo. Moreover, the clinical momentum was building at the end of 2004 with the anticipation of three to four Phase I human trials, the likely completion of one or more Phase I trials with positive data and the planned announcements at major medical meetings. 2. Volatility of Sangamo’s Stock Price. Sangamo’s stock price (which has had a trading range between $1.21 and $51.38 since Sangamo’s initial public offering in April 2000) tends to be volatile and significantly discounted as a result of the inherent uncertainty in the successful development of the underlying technology. The Company’s management believed that declines in Sangamo’s stock price were a result of certain external events (such as the event of September 11, 2001) and general investor sentiment of the biotechnology sector, and not Sangamo-specific activities. In addition, the Company recognized that, historically, reports of significant positive clinical outcomes can frequently result in a dramatic increase in the stock price of a biotechnology company over a relatively short time period. Management strongly believed this would be the case for Sangamo. Recent examples include: ViroPharm Inc. (VPHM) which, when it announced the advancement of a drug into Phase 1B clinical testing on May 24, 2005, the stock surged from below $5 per share to over $15 per share during the quarter after the announcement; and Vertex Pharmaceuticals Inc. (VRTX) which made a positive announcement about the efficacy of a drug in early clinical trial studies on May 10, 2005, and the stock rose from approximately $10 per share to $18 per share by the end of the quarter after the announcement. 3. Sangamo’s Liquidity. Throughout all periods in which the Company concluded that the impairment of this investment was temporary, Sangamo maintained cash and liquid investment reserves sufficient to continue to fund the ongoing development efforts for the technology for periods well in excess of one year. 4. Edwards Investment Intent. Throughout all periods in which the Company concluded that the impairment of this investment was temporary, the Company had, and presently has, the financial ability and intent to retain this investment indefinitely. Sangamo’s technology is considered important to the development of certain of the Company’s next generation products, and requires a long-term horizon for ongoing development of new technology. 5. Sangamo’s Technology Portfolio. Sangamo is a multi-technology (human therapeutics, drug discovery and plant agriculture) biotechnology company and has the ability to attract many different investors. In addition, the diversity of 6 technology applications serve to dilute the risk related to any one application failure. As a result of the systematic quarterly investment impairment reviews for Sangamo, the Company believed the decline in market value was temporary. Accordingly, the unrealized loss was not recorded in the Company’s income statements for years ended December 31, 2003 and 2004, and for the quarters ended March 31, 2005 and June 30, 2005. Investment Impairment in Third Quarter 2005 Year 2005 began with regulatory approvals for Sangamo’s diabetic neuropathy program to enter the clinical trial stage and for the Company’s critical limb ischemia program, and successful completion of the pre-clinical activities for the ischemic heart disease program. It was anticipated that as visibility for the Phase I clinical trials increased and as data were available, the recognized value surrounding these programs would significantly increase. The Company expected the market price of Sangamo’s stock to increase not only as a result of announcements of positive clinical trial results, but also other operational events. During the second half of 2005, Sangamo announced five significant key development